Aortic DiseasesNCT05872282
Percutaneous Endovascular Arch Repair Trial (PEART) Study
A study testing ZIPPER aortic arch stentgraft system in people with Aortic Diseases, run by Hangzhou Endonom Medtech Co., Ltd. at 3 sites in China.
Trial summary
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- ZIPPER aortic arch stentgraft system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 28 Apr 2023to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years old
- Patients diagnosed with aortic arch disease requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair; aortic arch aneurysms.
- Patients with suitable vascular conditions, including:
- Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Proximal anchoring zone diameter ≥ 24 mm and ≤ 47 mm;
- Proximal anchoring zone length ≥ 20 mm;
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- Innominate artery, left common carotid artery and left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- Suitable arterial access for endovascular interventional treatment;
- Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Evaluated by at least two investigators that the subjects are high-risk patients with more complications, poor general condition, high risk of deep hypothermic circulatory arrest, and not suitable for total arch replacement and other surgical procedures.
Who cannot join
- Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
- Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Patients that have experienced systemic infection within past three months;
- Neck surgery was performed within past three months;
- Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
- Patients with intestinal necrosis and lower limb ischemic necrosis;
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- Paraplegic patients;
- Heart transplant patients;
- Patients that have suffered MI or stroke within past three months;
- Patients with Class IV heart function (NYHA classification) or LVEF<30%
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the past three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), anemia (Hb < 90 g/L); coagulation dysfunction, thrombocytopenia (PLT count< 50 × 109/L);
- Patients with renal insufficiency， serum creatinine > 150 umol/L (or 3.0 mg/dl) and / or end-stage renal disease requiring dialysis, shall be determined by the investigator after a comprehensive analysis;
- Patients with severe liver dysfunction: ALT or AST exceeding 3 times the upper limit of norma, serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
- Patients who are allergic to contrast agents;
- Patients that are pregnant or breastfeeding;
- Patients with severe comorbidities who cannot tolerate anesthesia and surgery;
- Patients with a life expectancy of less than 12 months;
- Patients currently participating in other drug or device study;
- The investigator assessed that the patient was ineligible for the study for other diseases or abnormalities.
Trial locations and contacts
3 sites in 1 country.
Wayne W. Zhang contact
China3 sites, 3 recruiting
- Not yet recruiting
Jia Hu
Chengdu
Jia Hu, 1725194@qq.com
- Recruiting
Weiguo Fu
Shanghai
Weiguo Fu, fu.weiguo@zs-hospital.sh.cn
- Recruiting
Honglin Dong
Taiyuan
Honglin Dong, honglindong@sxmu.edu.cn
About this study
Official title: Feasible Study on a New Technique of ZIPPER Aortic Arch Stentgraft System in the Treatment of Aortic Arch Disease
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Read the detailed description
The feasible study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 24 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch disease, included aortic arch dissections, aneurysms, residual dissection following ascending aorta surgical operation.
- Conditions
- Aortic Diseases
- Being tested
- ZIPPER aortic arch stentgraft system
- Keywords
- Aortic Arch, Dissection, aneurysm
- Medical subject headings
- Aortic Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIPPER aortic arch stentgraft systemDevice
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
| Study group | Role | What they receive |
|---|---|---|
| ZIPPER aortic arch stentgraft system | Experimental | Not described Receives: Device: ZIPPER aortic arch stentgraft system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major device/procedure-related adverse events within 30 days post-operation.
Device or procedure related major adverse events included: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, fracture, migration, access vessel thrombosis or rupture, conversion to open surgery, death.
Measured: 30 days after intervention
Secondary outcomes (11)
Immediate postoperative technical success.
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure , and patent branch stents.
Measured: immediately after intervention
Incidence of Type I or Type III endoleaks.
Endoleak evaluated by DSA or CTA during operation and at 1 month, 6 months and 12 months after operation. Intraoperative endoleaks that were treated with adjuvant therapy were not documented. Endoleaks occurring in the same subject after completion of the procedure, and that were not treated at different visits, are counted as once.
Measured: 1 month, 6 months and 12 months post-intervention
Incidence of aortic arch stent graft migration.
CTA will be performed at 1, 6, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Migration is defined as the main and branched stents migrate more than 10 mm at postoperative follow-up compared with that 1 month post-intervention.
Measured: 1 month, 6 months and 12 months post-intervention
Postoperative branch vessel patency rate.
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate branch vessel revascularization and whether there is occlusion, stenosis, or stent thrombosis.
Measured: 1 month, 6 months and 12 months post-intervention
Results of aortic remodeling after aortic dissection surgery
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of aortic remodeling, including the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled.
Measured: 1 month, 6 months and 12 months post-intervention
Progression control of aortic aneurysm
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of progression control of aortic aneurysm. The maximum diameter of aortic aneurysm increases by ≤ 5 mm after 12 months of CTA examination compared with that before surgery.
Measured: 1 month, 6 months and 12 months post-intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention.
Whether or not the patient experienced surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention will be determined.
Measured: within 12 months post-intervention
Aortic-related mortality at 12 months post operation.
Refers to death caused by aortic rupture or endovascular treatment.
Measured: within 12 months post-intervention
All-cause mortality and major stroke within 12 months post-procedure.
All-cause mortality includes cardiac death, non-cardiac death, and unexpected death. Major stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days after stroke onset.
Measured: within 12 months post-intervention
Incidence of severe adverse events.
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Measured: within 12 months post-intervention
Incidence of device-related adverse events.
Device-related adverse event refers to an adverse medical event related to the use of test device during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event.
Measured: within 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start28 Apr 2023
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wayne W.Zhang , Seattle，Washington，USA
- Responsible party
- Sponsor
- Investigators
- Wayne W. Zhang, Principal investigator, Seattle，Washington，USAWeiguo Fu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872282
- Sponsor's protocol ID
- ZIPPER V1.0
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasible Study on a New Technique of ZIPPER Aortic Arch Stentgraft System in the Treatment of Aortic Arch Disease
- ClinicalTrials.gov ID
- NCT05872282
- Acronym / sponsor ID
- ZIPPER V1.0
- Conditions
- Aortic Diseases
- Keywords
- Aortic Arch, Dissection, aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Wayne W.Zhang , Seattle，Washington，USA
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Detailed description
The feasible study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 24 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch disease, included aortic arch dissections, aneurysms, residual dissection following ascending aorta surgical operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZIPPER aortic arch stentgraft system | Experimental | Device: ZIPPER aortic arch stentgraft system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 to 80 years old
- Patients diagnosed with aortic arch disease requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair; aortic arch aneurysms.
- Patients with suitable vascular conditions, including:
- Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Evaluated by at least two investigators that the subjects are high-risk patients with more complications, poor general condition, high risk of deep hypothermic circulatory arrest, and not suitable for total arch replacement and other surgical procedures.
Key exclusion criteria (20 listed)
- Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
- Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Patients that have experienced systemic infection within past three months;
- Neck surgery was performed within past three months;
- Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIPPER aortic arch stentgraft systemThe ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system. | Device | ZIPPER aortic arch stentgraft system |
Primary outcome
Freedom from major device/procedure-related adverse events within 30 days post-operation.
Time frame: 30 days after intervention
Device or procedure related major adverse events included: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, fracture, migration, access vessel thrombosis or rupture, conversion to open surgery, death.
11 secondary outcomes
Immediate postoperative technical success.
Time frame: immediately after intervention
Incidence of Type I or Type III endoleaks.
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of aortic arch stent graft migration.
Time frame: 1 month, 6 months and 12 months post-intervention
Postoperative branch vessel patency rate.
Time frame: 1 month, 6 months and 12 months post-intervention
Results of aortic remodeling after aortic dissection surgery
Time frame: 1 month, 6 months and 12 months post-intervention
Progression control of aortic aneurysm
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention.
Time frame: within 12 months post-intervention
Aortic-related mortality at 12 months post operation.
Time frame: within 12 months post-intervention
All-cause mortality and major stroke within 12 months post-procedure.
Time frame: within 12 months post-intervention
Incidence of severe adverse events.
Time frame: within 12 months post-intervention
Incidence of device-related adverse events.
Time frame: within 12 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W. Zhang contact
Wayne W. Zhang principal investigator
Seattle，Washington，USA
Weiguo Fu principal investigator
Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZIPPER aortic arch stentgraft system in people with Aortic Diseases, run by Hangzhou Endonom Medtech Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wayne W. Zhang (wwzhang08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major device/procedure-related adverse events within 30 days post-operation. (time frame: 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.